St. Jude Medical (NYSE:STJ) said today that the FDA granted pre-market approval for its next-generation Ilumien Optis device, which combines a pair of technologies to help guide physicians during stenting procedures.
St. Paul, Minn.-based St. Jude said the device, which it calls a percutaneous coronary intervention optimization system, unites fractional flow reserve technology with optical coherence tomography. The FFR device measures the blockage of blood flow inside coronary arteries; the OCT technology is an imaging technique used to provide real-time, 3D reconstruction of blood vessels, according to a press release.
St. Jude won CE Mark approval in the European Union for the Ilumien Optis system in May.
"The advancements in the Ilumien Optis system continue to build on St. Jude Medical’s leadership in providing innovative products that reduce health care costs and improve outcomes for patients battling coronary artery disease. This next-generation system is a scientific advancement that delivers critical information to physicians about the location and severity of disease within the coronary arteries, potentially resulting in better medical decision-making and overall cost-effective treatment," Frank Callaghan, president of the company’s cardiovascular and ablation technologies division, said in prepared remarks.